Neuroelectrics StarStim 32: Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation.
Neuroelectrics StarStim 32: Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.
Study summary
This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
* Hamilton Anxiety Scale (HAM-A) score \> 14
* Aged between 18 and 65 years, with no gender restrictions
* Receiving stable doses of immunosuppressive therapy for at least one month
* Expanded Disability Status Scale (EDSS) score ≤ 6
* Right-handed
* Willing to participate and sign informed consent
Exclusion Criteria:
* Recorded relapse within the past month
* Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
* Participation in any other clinical study within the past month or currently
* Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
* Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
* History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections
* Pregnant or breastfeeding women, or those planning to conceive in the near future
* Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders
* Presence of severe or unstable organic diseases
* Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection
* Any condition deemed unsuitable for study participation by the investigator
Primary outcome measure(s)
HAMA (Hamilton Anxiety Rating Scale) — From enrollment to the end of treatment at 1month A clinician-administered scale used to assess the severity of a patient's anxiety based on a series of symptoms.
Range: 0-56
Higher Scores: Indicate more severe anxiety.
Purpose: Used to evaluate the severity of anxiety symptoms in patients, primarily in clinical and research settings.
HADS (Hospital Anxiety and Depression Scale) — From enrollment to the end of treatment at 1month Description:
A self-report scale used to identify the levels of anxiety and depression in patients, particularly in a hospital setting. It consists of 14 items, split into two subscales: one for anxiety and one for depression.
Range: 0-42 (for each subscale)
Higher Scores: Indicate higher levels of anxiety or depression.
Purpose: Used for screening and evaluating the severity of anxiety and depression in patients, especially those with physical illnesses.
SPS (Social Phobia Scale) — From enrollment to the end of treatment at 1month A self-report scale used to measure the severity of social anxiety or social phobia.
Range: 0-120
Higher Scores: Indicate greater severity of social anxiety.
Purpose: Used to assess the intensity of social anxiety and its impact on the individual's daily life.
PSWQ (Penn State Worry Questionnaire) — From enrollment to the end of treatment at 1month A self-report scale used to assess the frequency and intensity of a person's worry.
Range: 16-80
Higher Scores: Indicate more frequent and intense worry.
Purpose: Primarily used in research and clinical settings to evaluate generalized anxiety and worry tendencies.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.